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Rationale and Design of the TARGET-EFT Trial: Multicomponent Intervention for Frail and Pre-frail Patients Hospitalized with Acute Cardiac Conditions.

ABSTRACT:

Background

With the aging population and rising rates of cardiovascular disease (CVD), cardiologists and cardiac surgeons are encountering a growing number of frail older patients that have complex cardiac and non-cardiac issues. Measuring frailty provides valuable prognostic information to help personalize treatment decisions. However, there is minimal evidence on multicomponent frailty interventions in this setting. The TARGET-EFT (The MulTicomponent Acute Intervention in FRail GEriatric PaTients with cardiovascular disease using the Essential Frailty Toolset) trial aims to target physical and non-physical frailty deficits to improve health-related quality of life and hospital-acquired disability in frail patients hospitalized with CVD.

Methods

The TARGET-EFT trial is a single-center parallel-group randomized clinical trial in frail and pre-frail older adults ≥65 years admitted to the cardiovascular unit (CVU) at the Jewish General Hospital, Montreal, Quebec. The trial will compare usual inpatient care to a multicomponent intervention targeting physical weakness, cognitive impairment, malnutrition, and anemia. Outcomes of interest in both groups will be assessed at three time points: (1) study enrollment, (2) discharge from the CVU, and (3) 30 days after hospital discharge.

Conclusions

The overarching goal is to treat patients' frailty in parallel with their CVD, and in doing so, optimize patient functional losses while in-hospital and shortly thereafter. The results of this trial will inform best practices for patient-centered care in this vulnerable patient group.

SUBMITTER: Fountotos R

PROVIDER: S-EPMC8900965 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Rationale and Design of the TARGET-EFT Trial: Multicomponent Intervention for Frail and Pre-frail Patients Hospitalized with Acute Cardiac Conditions.

Fountotos R R Munir H H Ahmad F F Goldfarb M M Afilalo J J

The journal of nutrition, health & aging 20220101 3

<h4>Background</h4>With the aging population and rising rates of cardiovascular disease (CVD), cardiologists and cardiac surgeons are encountering a growing number of frail older patients that have complex cardiac and non-cardiac issues. Measuring frailty provides valuable prognostic information to help personalize treatment decisions. However, there is minimal evidence on multicomponent frailty interventions in this setting. The TARGET-EFT (The MulTicomponent Acute Intervention in FRail GEriatr ...[more]

PMID: 35297472

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Project description:AimsFrailty is disproportionately prevalent in cardiovascular disease patients and exacerbated during hospital admissions, heightening the risk for adverse events and functional decline. Using the Essential Frailty Toolset (EFT) to target physical weakness, cognitive impairment, malnourishment, and anaemia, we tested a multicomponent targeted intervention to de-frail older adults with acute cardiovascular conditions during their hospital admission.Methods and resultsThe TARGET-EFT trial was a single-center randomized clinical trial at the Jewish General Hospital, Montreal, Canada. We compared a multicomponent de-frailing intervention with usual clinical care. Intervention group patients received exercise, cognitive stimulation, protein supplementation, and iron replacement, as required. In this study, the primary outcome was frailty, as assessed by the SPPB score (Short Physical Performance Battery) at discharge, and the secondary outcome was the SARC-F score (Strength, Assistance walking, Rising from chair, Climbing, Falls) assessed 30 days later. The analysis consisted of 135 patients (mean age of 79.3 years; 54% female) who survived and completed the frailty assessments.Compared with control patients, intervention group patients had a 1.52-point superior SPPB score and a 0.74-point superior SARC-F score. Subgroup analysis suggested that patients with low left ventricular ejection fraction may have attenuated benefits, and that patients who underwent invasive cardiac procedures had the greatest benefits from the intervention.ConclusionWe achieved our objective of de-frailing older cardiac inpatients on a short-term basis by improving their physical performance and functioning using a pragmatic multicomponent intervention. This could have positive impacts on their clinical outcomes and ability to maintain independent living in the future.One sentence summaryThe multicomponent intervention targeted to the deficits of vulnerable older adults hospitalized with acute cardiovascular diseases successfully de-frailed them on a short-term basis, which can have positive implications on their post-discharge health outcomes.

Project description:ObjectiveTo determine whether a multicomponent intervention based on physical activity with technological support and nutritional counselling prevents mobility disability in older adults with physical frailty and sarcopenia.DesignEvaluator blinded, randomised controlled trial.Setting16 clinical sites across 11 European countries, January 2016 to 31 October 2019.Participants1519 community dwelling men and women aged 70 years or older with physical frailty and sarcopenia, operationalised as the co-occurrence of low functional status, defined as a short physical performance battery (SPPB) score of 3 to 9, low appendicular lean mass, and ability to independently walk 400 m. 760 participants were randomised to a multicomponent intervention and 759 received education on healthy ageing (controls).InterventionsThe multicomponent intervention comprised moderate intensity physical activity twice weekly at a centre and up to four times weekly at home. Actimetry data were used to tailor the intervention. Participants also received personalised nutritional counselling. Control participants received education on healthy ageing once a month. Interventions and follow-up lasted for up to 36 months.Main outcome measuresThe primary outcome was mobility disability (inability to independently walk 400 m in <15 minutes). Persistent mobility disability (inability to walk 400 m on two consecutive occasions) and changes from baseline to 24 and 36 months in physical performance, muscle strength, and appendicular lean mass were analysed as pre-planned secondary outcomes. Primary comparisons were conducted in participants with baseline SPPB scores of 3-7 (n=1205). Those with SPPB scores of 8 or 9 (n=314) were analysed separately for exploratory purposes.ResultsMean age of the 1519 participants (1088 women) was 78.9 (standard deviation 5.8) years. The average follow-up was 26.4 (SD 9.5) months. Among participants with SPPB scores of 3-7, mobility disability occurred in 283/605 (46.8%) assigned to the multicomponent intervention and 316/600 (52.7%) controls (hazard ratio 0.78, 95% confidence interval 0.67 to 0.92; P=0.005). Persistent mobility disability occurred in 127/605 (21.0%) participants assigned to the multicomponent intervention and 150/600 (25.0%) controls (0.79, 0.62 to 1.01; P=0.06). The between group difference in SPPB score was 0.8 points (95% confidence interval 0.5 to 1.1 points; P<0.001) and 1.0 point (95% confidence interval 0.5 to 1.6 points; P<0.001) in favour of the multicomponent intervention at 24 and 36 months, respectively. The decline in handgrip strength at 24 months was smaller in women assigned to the multicomponent intervention than to control (0.9 kg, 95% confidence interval 0.1 to 1.6 kg; P=0.028). Women in the multicomponent intervention arm lost 0.24 kg and 0.49 kg less appendicular lean mass than controls at 24 months (95% confidence interval 0.10 to 0.39 kg; P<0.001) and 36 months (0.26 to 0.73 kg; P<0.001), respectively. Serious adverse events occurred in 237/605 (39.2%) participants assigned to the multicomponent intervention and 216/600 (36.0%) controls (risk ratio 1.09, 95% confidence interval 0.94 to 1.26). In participants with SPPB scores of 8 or 9, mobility disability occurred in 46/155 (29.7%) in the multicomponent intervention and 38/159 (23.9%) controls (hazard ratio 1.25, 95% confidence interval 0.79 to 1.95; P=0.34).ConclusionsA multicomponent intervention was associated with a reduction in the incidence of mobility disability in older adults with physical frailty and sarcopenia and SPPB scores of 3-7. Physical frailty and sarcopenia may be targeted to preserve mobility in vulnerable older people.Trial registrationClinicalTrials.gov NCT02582138.

Project description:BackgroundFrail cardiac surgery patients have an increased risk of worse postoperative outcomes. The purpose of this study was to evaluate the implementation of a novel Telehealth Home monitoring Enhanced-Frailty And Cardiac Surgery (THE-FACS) intervention and determine its impact on clinical outcomes in frail patients post-cardiac surgery.MethodsFrail/vulnerable patients defined by Edmonton Frailty Scale (EFS > 4) undergoing cardiac surgery were prospectively enrolled (November 2019 -March 2020) at the New Brunswick Heart Centre. Exclusion criteria included age < 55 years, emergent status, minimally invasive surgery, lack of home support, and > 10-days postoperative hospital stay. Following standard training on THE-FACS, participants were sent home with a tablet device to answer questions about their health/recovery and measure blood pressure for 30-consecutive days. Transmitted data were monitored by trained cardiac surgery follow-up nurses. Patients were contacted only if the algorithm based on the patient's self-collected data triggered an alert. Patients who completed the study were compared to historical controls. The primary outcome of interest was to determine the number of patients that could complete THE-FACS; secondary outcomes included participant/caregiver satisfaction and impact on hospital readmission.ResultsWe identified 86 eligible (EFS > 4), out of 254 patients scheduled for elective cardiac surgery during the study period (vulnerable: 34%). The patients who consented to participate in THE-FACS (64/86, 74%) had a mean age of 69.1 ± 6.4 years, 25% were female, 79.7% underwent isolated Coronary Artery Bypass Graft (CABG) and median EFS was 6 (5-8). 29/64 (45%) were excluded post-enrollment due to prolonged hospitalization (15/64) or requirement for hospital-to-hospital transfer (12/64). Of the remaining 35 patients, 21 completed the 30-day follow-up (completion rate:60%). Reasons for withdrawal (14/35, 40%) were mostly due to technical difficulties with the tablet. Hospital readmission, although non-significant, was reduced in THE-FACS participants compared to controls (0% vs. 14.3%). A satisfaction survey revealed > 90% satisfaction and ~ 67% willingness to re-use a home monitoring device.ConclusionsTHE-FACS intervention can be used to successfully monitor vulnerable patients returning home post-cardiac surgery. However, a significant number of frail patients could not benefit from THE-FACS given prolonged hospitalization and technological challenges. Our findings suggest that despite overall excellent satisfaction in participants who completed THE-FACS, there remain major challenges for wide-scale implementation of technology-driven home monitoring programs as only 24% completed the study.

Project description:BackgroundOlder cardiac patients are at high risk of readmission and mortality. Transitional care interventions (TCIs) might contribute to the prevention of adverse outcomes. The Cardiac Care Bridge program was a randomized nurse-coordinated TCI combining case management, disease management and home-based rehabilitation for hospitalized frail older cardiac patients. This qualitative study explored the experiences of patients' participating in this study, as part of a larger process evaluation as this might support interpretation of the neutral study outcomes. In addition, understanding these experiences could contribute to the design and application of future transitional care interventions for frail older cardiac patients.MethodsA generic qualitative approach was used. Semi-structured interviews were performed with 16 patients ≥70 years who participated in the intervention group. Participants were selected by gender, diagnosis, living arrangement and hospital of inclusion. Data were analysed using thematic analysis. In addition, quantitative data about intervention delivery were analysed.ResultsThree themes emerged from the data: 1) appreciation of care continuity; 2) varying experiences with recovery and, 3) the influence of an existing care network. Participants felt supported by the transitional care intervention as they experienced post-discharge support and continuity of care. The perceived contribution of the program in participants' recovery varied. Some participants reported physical improvements while others felt impeded by comorbidities or frailty. The home visits by the community nurse were appreciated, although some participants did not recognize the added value. Participants with an existing healthcare provider network preferred to consult these providers instead of the providers who were involved in the transitional care intervention.ConclusionOur results contribute to an explanation of the neutral study of a nurse-coordinated transitional care intervention. For future purpose, it is important to identify which patients might benefit most from TCIs. Furthermore, the intensity and content of TCIs could be more personalized by tailoring interventions to older cardiac patients' needs, considering their frailty, self-management skills and existing formal and informal caregiver networks.

Dataset Information

Rationale and Design of the TARGET-EFT Trial: Multicomponent Intervention for Frail and Pre-frail Patients Hospitalized with Acute Cardiac Conditions.

Background

Methods

Conclusions

Publications

Rationale and Design of the TARGET-EFT Trial: Multicomponent Intervention for Frail and Pre-frail Patients Hospitalized with Acute Cardiac Conditions.

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